Use of Electronic Personal Health Records to Improve Medication Adherence
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03018197|
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Medication Adherence||Other: Medication Education||Not Applicable|
Three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their MyChart account. The newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. Newsletters will be developed through a review of the FDA-approved prescribing information, general tertiary references, and a search of PubMed and drafted with guidance from a Drug Information Specialist at Manchester University College of Pharmacy as well as reviewed by the research staff.
Descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. Difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. Patient medication adherence will be correlated from the Pharmacy refill data to determine if the Intervention Group is more compliant than the Control Group. Multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Electronic Personal Health Records to Improve Medication Adherence Among Non-Valvular Atrial Fibrillation Patients: A Pilot Study|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Medication Education
Patients will receive training on the use of the personal health record and health education via the personal health record.
Other: Medication Education
Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
No Intervention: No Medication Education
Patients will receive the current standard of care for the personal health record. Patients will not receive training on the use of the personal health record or health education via the personal health record.
- Medication Adherence evaluated through medication possession ratios [ Time Frame: 3 months during study ]
- Patient Engagement evaluated through Patient Activation Measure (PAM) [ Time Frame: 3 months during study ]
- Medication Knowledge evaluated through 5-question survey [ Time Frame: 3 months during study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018197
|United States, Indiana|
|Parkview Research Center; Parkview Health|
|Fort Wayne, Indiana, United States, 46845|
|Principal Investigator:||Michael Mirro, MD||Parkview Health|
|Principal Investigator:||Ozlem Ersin, PhD||Manchester University College of Medicine|